EEG/MECG/EMG Evaluating the Severity of Aortic Stenosis, Heart Failure and Ischemic Stroke Through an Artificial Intelligenceassisted System.

Assessment of Brain-heart-muscle Axis Using EEG/MECG/EMG Combo Machine for Evaluating the Severity of Aortic Stenosis, Heart Failure and Ischemic Stroke Through an Artificial Intelligenceassisted System.

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05716659

Enrollment

750

Registered

2023-02-08

Start date

2023-05-30

Completion date

2032-08-31

Last updated

2023-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CVD

Keywords

heart failure, aortic stenosis, ischemic stroke

Brief summary

The specific objectives and methods of this project are: (1) To test the feasibility and accuracy of integrating EEG, MECG and EMG for detecting the severity of diseases such as aortic stenosis, heart failure and ischemic stroke. (2) Improve the accuracy of this multi-channel brain-heart-muscle device by using an artificial intelligence auxiliary system. (3) Provide tailor-made interdisciplinary treatment strategies for patients with different disease states.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Age≥20 year-old 2. Healthy subjects or patients with A. Metabolic syndrome (MetS) ；B. HF with reduced ejection fractions (HFrEF, defined by left ventricular ejection fraction≤40%) and current or previous symptoms of HF；C. Severe aortic stenosis (defined aortic valve area \< 1.0 cm2 or mean pressure gradient ≥ 40 mmHg), preparing to receive transcatheter aortic valve replacement ；D. Acute ischemic stroke and admitted to stroke intensive care unit (ICU), within 24 hours after onset The criteria of MetS includes: 1. Abdominal obesity: waist circumference (for Asians) ≥ 90 cm in men and ≥ 80 cm in women; 2. Hyperglycemia: serum fasting glucose level ≥ 100 mg/dl, or receiving drug treatment for elevated blood sugar; 3. Reduced high-density lipoprotein cholesterol (HDL-C): serum HDL-C \< 40 mg/dl in men and \< 50 mg/dl in women or on cholesterol drug treatment; 4. Elevated triglycerides: serum triglyceride ≥ 150 mg/dl or on drug treatment of hypertriglyceridemia; 5. Hypertension: systolic blood pressure ≥ 130 mmHg, diastolic blood pressure ≥ 85 mmHg, or on antihypertensive drug treatment.

Exclusion criteria

1. Under treatment for malignancy 2. Currently receiving immunosuppressants 3. Modified Rankin Scale (mRS) ≥2 prior to the stroke 4. Symptomatic HF in patients with acute ischemic stroke 5. Unable to perform neurocognitive function test 6. Unable to evaluate the physical activity using questionnaire or 6-minute walk test 7. Unable to cooperate with examinations using 3E combo machine.

Design outcomes

Primary

Measure	Time frame	Description
Composite cardiovascular outcome	up to 10 years	Composite endpoint: Major adverse cardiac events (MACE): myocardial infarction, stroke, hospitalization for heart failure, or cardiovascular death)

Countries

Taiwan

Contacts

Primary ContactHsien-Li Kao, M.D., Ph.D.

hsienli_kao@yahoo.com02-23123456

Backup ContactChih-Fan Yeh, M.D., Ph.D.

nicholas.yeh@gmail.com02-23123456

Outcome results